Diabetes Mellitus Type 2STRIDENCT07544407
STRIDE: Supporting Early Diabetes Self-Management for Parents
A study testing STRIDE Program in people with Diabetes Mellitus Type 2, run by Kaiser Permanente at 1 site in United States.
Trial summary
This study will test STRIDE (SupporTing paRents with DiabEtes), a virtually delivered program that helps adults ages 21-44 who were recently diagnosed with type 2 diabetes and are caring for a child ages 2-14 within Kaiser Permanente Northern California. Read more about this study
- Who is it for?
- Ages 21 to 44 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- STRIDE Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Kaiser Permanente Northern California members newly diagnosed with T2D (within the past 5 years)
- Proficient in English
- Primary caregivers to ≥1 child (ages 2-14 years at time of enrollment)
- Can receive text messages
- Able to participate in a virtual session
Who cannot join
- Pregnant women
- Type 1 Diabetes
- Unable to receive text messages
- Unable to participate in a virtual session
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Kaiser Permanente Northern California
Pleasanton, California, 94588
About this study
Official title: A Pilot Trial of an Intervention to Support Initial Type 2 Diabetes Self-management Among Younger Adults With Children (STRIDE)
This study will test STRIDE (SupporTing paRents with DiabEtes), a virtually delivered program that helps adults ages 21-44 who were recently diagnosed with type 2 diabetes and are caring for a child ages 2-14 within Kaiser Permanente Northern California. STRIDE focuses on practical skills for everyday life, with sessions on Prioritizing Self-Care, Eating Well Together, and Getting Active as a Family.
Read the detailed description
To date, most tailored programs have focused only on cultural tailoring (based on race and ethnicity) and not on a patient's life stage. To address this gap, we developed a self-management support program, STRIDE (SupporTing paRents with DiabEtes), designed for adults with type 2 diabetes who are raising children.
This study will evaluate the STRIDE program in a randomized pilot design to understand how well it meets the needs of younger adults with type 2 diabetes who are raising children. The study will examine whether STRIDE helps participants build early self management skills and reduces challenges that can interfere with diabetes care. Findings from this pilot will provide information needed to refine the program and guide future implementation.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- STRIDE Program
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRIDE ProgramBehavioural
Participants randomized to the intervention arm will be enrolled in the STRIDE program, a clinician-led virtually delivered program designed specifically for adults with type 2 diabetes who are raising children.
Through 3 virtual sessions, the program provides practical, family-centered self-management support. Participants also receive texts to reinforce session content, family wellness kits, and session recordings as needed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: STRIDE Program | Experimental | Participants enrolled in the STRIDE arm will be invited to attend the live and recorded sessions let by a clinician and receive 24 tailored text messages, in addition to their usual diabetes care. Receives: Behavioral: STRIDE Program |
| Usual Care | No intervention | This arm will continue to receive their usual diabetes care. After completing 6-month outcome assessments, they will be offered an opportunity to participate in the STRIDE program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Distress Scale (DDS)
Diabetes Distress Scale (DDS), a validated 17-item scale covering 4 domains: emotional burden, physician-related distress, regimen-related distress, and interpersonal distress. Each item is rated on a 6-point scale (1 = not a problem to 6 = a very serious problem), with higher scores indicating greater diabetes-related distress (worse outcome).
Measured: Baseline and 4-5 months following enrollment
Diabetes Self-Efficacy
The Diabetes Self-Efficacy Scale is a validated 8-item measure that assesses an individual's confidence in performing diabetes self-care activities. Items are rated on a 10-point scale (1 = not at all confident to 10 = very confident), with higher scores indicating greater self-efficacy.
Measured: Baseline and 4-5 months following enrollment
Secondary outcomes (6)
HbA1c at 6 Months
HbA1c will be obtained from the electronic health record using values collected through routine clinical care. The HbA1c value closest to 6 months post-enrollment will be used.
Measured: 6-Months Following Enrollment
Completion of HbA1c Monitoring
Completion of at least one HbA1c test within 6 months post-enrollment will be assessed using electronic health record data.
Measured: 6-Months Following Enrollment
T2D-related care
Healthcare utilization related to T2D management will be abstracted from the electronic health record, including primary care visits, telemedicine contacts, T2D care manager visits, dietitian visits, wellness coaching contacts, and participation in health education classes during the 6-month study period.
Measured: 6-Months Following Enrollment
Medication Use
T2D medication initiation (filling of a first T2D-related prescription) and adherence (refill of an existing T2D medication prescription) will be assessed using KPNC pharmacy records.
Measured: 6-Months Following Enrollment
Self-Reported T2D Self-Management
Self-reported T2D self-management will be assessed using the Summary of Diabetes Self-Care Activities (SDSCA), a validated measure of diabetes self-care behaviors over the prior 7 days. Domains assessed include general diet, specific diet (fat intake), physical activity, blood glucose monitoring, and medication taking. Assessed at baseline and follow-up (4-5 months post-enrollment).
Measured: 6-Months Following Enrollment
Report of Children's Health-Related Behaviors
Parent-reported child health behaviors (youngest child ages 2-14) will be assessed using a combination of questions from KPNC pediatric clinical care and study-developed items. KPNC-derived items assess fruit and vegetable intake, sugar-sweetened beverage consumption, screen time, and physical activity. Study-developed items assess shared parent-child physical activity and child involvement in food preparation and grocery shopping. Items are analyzed individually; response options vary by item (yes/no, frequency, or number of days).
Measured: Baseline and 4-5 months following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start8 Jun 2026
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anjali Gopalan, MD, MS, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544407
- Sponsor's protocol ID
- 2315563-1
- Other IDs
- R01DK139225
- Acronym
- STRIDE
- Status last verified
- Feb 2026
- First submitted
- 15 Apr 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of an Intervention to Support Initial Type 2 Diabetes Self-management Among Younger Adults With Children (STRIDE)
- ClinicalTrials.gov ID
- NCT07544407
- Acronym / sponsor ID
- STRIDE / 2315563-1
- Conditions
- Diabetes Mellitus Type 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test STRIDE (SupporTing paRents with DiabEtes), a virtually delivered program that helps adults ages 21-44 who were recently diagnosed with type 2 diabetes and are caring for a child ages 2-14 within Kaiser Permanente Northern California. STRIDE focuses on practical skills for everyday life, with sessions on Prioritizing Self-Care, Eating Well Together, and Getting Active as a Family.
Detailed description
To date, most tailored programs have focused only on cultural tailoring (based on race and ethnicity) and not on a patient's life stage. To address this gap, we developed a self-management support program, STRIDE (SupporTing paRents with DiabEtes), designed for adults with type 2 diabetes who are raising children.
This study will evaluate the STRIDE program in a randomized pilot design to understand how well it meets the needs of younger adults with type 2 diabetes who are raising children. The study will examine whether STRIDE helps participants build early self management skills and reduces challenges that can interfere with diabetes care. Findings from this pilot will provide information needed to refine the program and guide future implementation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: STRIDE Program | Experimental | Behavioral: STRIDE ProgramParticipants enrolled in the STRIDE arm will be invited to attend the live and recorded sessions let by a clinician and receive 24 tailored text messages, in addition to their usual diabetes care. |
| Usual Care | No intervention | –This arm will continue to receive their usual diabetes care. After completing 6-month outcome assessments, they will be offered an opportunity to participate in the STRIDE program |
Who may qualify
- Ages
- 21 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Kaiser Permanente Northern California members newly diagnosed with T2D (within the past 5 years)
- Proficient in English
- Primary caregivers to ≥1 child (ages 2-14 years at time of enrollment)
- Can receive text messages
- Able to participate in a virtual session
Key exclusion criteria (4 listed)
- Pregnant women
- Type 1 Diabetes
- Unable to receive text messages
- Unable to participate in a virtual session
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STRIDE ProgramParticipants randomized to the intervention arm will be enrolled in the STRIDE program, a clinician-led virtually delivered program designed specifically for adults with type 2 diabetes who are raising children. Through 3 virtual sessions, the program provides practical, family-centered self-management support. Participants also receive texts to reinforce session content, family wellness kits, and session recordings as needed. | Behavioural | Experimental: STRIDE Program |
Primary outcome
Diabetes Distress Scale (DDS)
Time frame: Baseline and 4-5 months following enrollment
Diabetes Distress Scale (DDS), a validated 17-item scale covering 4 domains: emotional burden, physician-related distress, regimen-related distress, and interpersonal distress. Each item is rated on a 6-point scale (1 = not a problem to 6 = a very serious problem), with higher scores indicating greater diabetes-related distress (worse outcome).
Diabetes Self-Efficacy
Time frame: Baseline and 4-5 months following enrollment
The Diabetes Self-Efficacy Scale is a validated 8-item measure that assesses an individual's confidence in performing diabetes self-care activities. Items are rated on a 10-point scale (1 = not at all confident to 10 = very confident), with higher scores indicating greater self-efficacy.
6 secondary outcomes
HbA1c at 6 Months
Time frame: 6-Months Following Enrollment
Completion of HbA1c Monitoring
Time frame: 6-Months Following Enrollment
T2D-related care
Time frame: 6-Months Following Enrollment
Medication Use
Time frame: 6-Months Following Enrollment
Self-Reported T2D Self-Management
Time frame: 6-Months Following Enrollment
Report of Children's Health-Related Behaviors
Time frame: Baseline and 4-5 months following enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anjali Gopalan, MD, MS principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STRIDE Program in people with Diabetes Mellitus Type 2, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Distress Scale (DDS) (time frame: Baseline and 4-5 months following enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.